Comparative Study of New Classification and Traditional Classification of Radioactive Oropharyngeal Mucositis

A Comparative Study on the Evaluation Consistency Between the New Type and the Traditional Grade of Radioactive Oropharyngeal Mucositis and the Exploration of Blood Markers

Radiation oropharyngeal mucositis is one of the most painful side effects of radiotherapy in patients with head and neck tumors. However, the traditional radioactive oropharyngeal mucositis grading system has the problem of poor evaluation consistency. To solve this problem, we innovatively classify radiation oropharyngeal mucositis into four types according to the four-stage histopathological changes of acute radiation injury: (1) congestive; (2) Scattered erosion type; (3) Fusion erosion type; (4) Ulcer type. We intend to conduct a multicenter observational cohort study to compare the consistency of different physicians in the assessment of radiation oropharyngeal mucositis with new and traditional classifications, and to explore changes in blood markers of different types of oropharyngeal mucositis using clinical residual blood samples.

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Cancer; Radiation-Induced Mucositis

Detailed Description

Since this is an observational study, no additional visits, laboratory analyses, or evaluations beyond the routine clinical practice requirements are necessary. Patients must sign the latest informed consent form (ICF) approved by the ethics committee before data collection is carried out. After obtaining the patient's consent, clinical routine diagnosis and treatment information will be collected.

The study is divided into three parts. The first part compares the consistency of results among different methods used to assess mucositis. The research process involves having different doctors assess the same patient at the same stage using a specific grading method three times, and taking the results of more than two of these assessments as the internal unified results of that grading method (each patient can be assessed and data recorded every 1-2 weeks during radiotherapy). After obtaining the internal unified results of the three mucositis grading methods, the consistency of results among different methods used for assessment is compared.

The second part first determines the internal consistency of doctor evaluations for four methods (the traditional three mucositis grading methods and the new classification method), and then uses the consistency results of each method to compare the stability of the assessments. The research process involves having different doctors assess the same patient at the same stage using a specific method three times. Each patient can be assessed and data recorded every 1-2 weeks during radiotherapy. The consistency of evaluations among different doctors for this method is obtained. Finally, this consistency is used to compare the stability of the assessments between different methods.

The third part compares the consistency of results between the assessment using the new mucositis classification method and the patient's self-assessment. The research process involves having different doctors assess the same patient at the same stage using the new classification method three times, and taking the results of more than two of these assessments as the internal unified result of the new classification method (each patient can be assessed and data recorded every 1-2 weeks during radiotherapy). After obtaining the internal unified results of the new classification method and the patient's self-assessment results, the consistency of results between using the new classification method and the patient's self-assessment is compared.

• Study Type: Observational
• Enrollment (Estimated): 264

Contacts and Locations

• Study Contact: Name: Jian Guan, M.D; Phone Number: +86-13632102247; Email: guanjian5461@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Recruiting
      • Southern Medical University
      • Contact: Jian Guan, M.D; Phone Number: 86+13632102247; Email: guanjian5461@163.com
    • Huizhou, Guangdong, China, 516000
      • Not yet recruiting
      • Huizhou Central People's Hospital
      • Contact: Yunming Tian
    • Jieyang, Guangdong, China, 522000
      • Not yet recruiting
      • Jieyang People's Hospital
      • Contact: Peibao Lai; Phone Number: 86+15975196057; Email: boa71@139.com
    • Meizhou, Guangdong, China, 514000
      • Not yet recruiting
      • Meizhou People's Hospital, Meizhou Academy of Medical Sciences Meizhou
      • Contact: Jianda Sun

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The subjects in this study were head and neck tumor patients receiving radiotherapy

Description

Inclusion Criteria:

• Voluntarily sign informed consent;
• Age 18 or older on the date of signing the informed consent;
• Histologically confirmed head and neck tumor, radiotherapy or chemoradiotherapy.

Exclusion Criteria:

• They also have other uncontrolled serious medical conditions, such as unstable heart disease requiring treatment, poorly controlled diabetes (fasting blood glucose > 1.5× the upper limit of normal), mental illness, and a history of severe allergies

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inter-rater consistency among doctors	Different physician assessments of agreement (percentage) were directly compared between the new and traditional classifications. Consistency refers to the proportion of assessments made by two doctors that are the same.	Through study completion, up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Consistency in assessment between doctors and patients	In the new classification, the consistency (percentage) of assessment between doctors and patients was compared. Consistency refers to the proportion of times where the assessments made by the two doctors were the same.	Through study completion, up to 3 years
The assessment period	The assessment times used respectively for different assessment methods	Through study completion, up to 3 years
the satisfaction of patients	the satisfaction of patients	Through study completion, up to 3 years
the satisfaction of doctors	the satisfaction of doctors	Through study completion, up to 3 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploration of blood biomarkers related to the classification of radioactive oropharyngeal mucositis	Exploration of blood biomarkers related to the classification of radioactive oropharyngeal mucositis	Through study completion, up to 3 years

Collaborators and Investigators

• Sponsor: Nanfang Hospital, Southern Medical University
• Investigators: Principal Investigator: Jian Guan, M.D, Nanfang Hospital, Southern Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: March 6, 2024
• First Submitted That Met QC Criteria: March 6, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): July 16, 2025
• Last Update Submitted That Met QC Criteria: July 13, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Head and Neck Cancer; Radiation oropharyngeal mucositis
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Head and Neck Neoplasms; Mucositis
• Other Study ID Numbers: NFEC-2024-098

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No